Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer
This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Conditions:
🦠 Stage I Prostate Cancer AJCC v8 🦠 Stage II Prostate Cancer AJCC v8 🦠 Stage III Prostate Cancer AJCC v8 🦠 Stage IVA Prostate Cancer AJCC v8
🗓️ Study Start (Actual) 30 May 2019
🗓️ Primary Completion (Estimated) 1 November 2025
✅ Study Completion (Estimated) 1 November 2025
👥 Enrollment (Estimated) 178
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Houston, Texas, United States
📍 League City, Texas, United States
📍 Sugar Land, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Men age 18 or older
    • * Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted
    • * Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology
    • * For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of \>= 0.1. PSA \>= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT)
    • * Patient diagnosed with Gleason score of 6-10
    • * Eastern Cooperative Oncology Group (ECOG) performance 0-2
    • * Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy
    • * If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer

    Exclusion Criteria:

    • * Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
    • * Neoadjuvant chemotherapy before or after prostatectomy
    • * History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
    • * History of severe active co-morbidity or uncontrolled diabetes
    • * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • * Transmural myocardial infarction within the last 6 months
    • * Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
    • * End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 January 2019
  • First Submitted that Met QC Criteria 11 June 2019
  • First Posted 17 June 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024